Catalog Number

27307

Brand Name

Dukal

Version/Model Number

27307

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162258,K162258,K162258

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

cf3cc5ea-363a-4fce-8117-7c23b79c171c

Public Version Date

May 23, 2022

Public Version Number

2

DI Record Publish Date

March 30, 2022

Package DI Number

20665973027207

Quantity per Package

5

Contains DI Package

10665973027200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case